CytoSorbents Corporation CTSO released an update on the initial data analysis of primary safety and effectiveness endpoints and the final independent Data and Safety Monitoring Board for the pivotal U.S. and Canadian STAR-T trial.
The trial assessed DrugSorb-ATR’s ability to reduce perioperative bleeding in 140 enrolled patients on AstraZeneca Plc AZN Brilinta/Brilique (ticagrelor) undergoing cardiothoracic surgery before completing the recommended washout period.
Patients were randomized in a 1:1 ratio to receive either DrugSorb-ATR or a sham device during cardiopulmonary bypass, with a primary composite effectiveness endpoint measuring perioperative bleeding.
The initial data analysis showed that the study did not meet the primary effectiveness endpoint in the overall patient population undergoing different cardiac surgeries.
The study demonstrated reduced bleeding complications in patients in the pre-specified isolated coronary artery bypass graft surgery population, representing more than 90% of the overall study population.
The independent DSMB conducted the final review and concluded there were no device safety issues, meeting the study’s primary safety endpoint.
The company expects to complete the analysis of the full trial results in the next several weeks.
Pending this final analysis, the company believes the safety and effectiveness data from STAR-T may support the regulatory submission of DrugSorb-ATR to the FDA and Health Canada.
DrugSorb-ATR is an investigational blood purification system to remove multiple classes of blood thinners during cardiothoracic surgery. It connects to a heart-lung machine blood circuit and removes these drugs while the surgery is ongoing.
DrugSorb-ATR has already received two FDA Breakthrough Device Designations to remove the anti-platelet agent, Brilinta and to remove the direct oral anticoagulants, Bristol Myers Squibb & Co BMY/Pfizer Inc’s PFE Eliquis (apixaban) and Johnson & Johnson’s JNJ Xarelto (rivaroxaban), during cardiothoracic surgery.
Price Action: CTSO shares are down 34.9% at $1.06 during the premarket session on the last check Thursday.